Botox vs Occlusal Splint for Masseter Pain

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federal University of Pelotas
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; onabotulinumtoxinA; Salicylic Acid

Criteria

Inclusion Criteria:

• Between 18 and 70 years old;

• at least 20 teeth in the mouth;

• occlusal stability;

• presenting pain in face muscles.

Exclusion Criteria:

• Angle's Class III

• Kennedy's Class II or I removable partial denture wearer;

• Complete denture wearer;

• Individuals that have taken any anti inflammatory drugs in the last 3 months;

• Individuals with temporomandibular joint disorders.